FDA.report

McKesson

Primary DI
00612479225909
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-4806
Device description
Dressing Retention Tape 6 in. x 10 yds.
Published
2019-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479225909PackageGS112In Commercial Distribution
00612479225893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479225909006124792259096124792259090612479225909
00612479225893006124792258936124792258930612479225893

GMDN Terms

TermDefinition
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter, lamp); it is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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